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Director of Regulatory Affairs

United States, San Francisco Bay Area · Job Posted May 03, 2026
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Job Description

Hemab seeks a Director, Regulatory Affairs who will be responsible for developing and executing innovative global regulatory strategies for the global development of candidates for the treatment of rare, hematological disorders. This position will define, develop, and lead execution of strategies to maximize global regulatory success and achieve program objectives for complex development projects in the rare disease space. The Director Regulatory Affairs will be response for keeping abreast of new developments in regulatory science and maintaining oversight on the evolving regulatory landscape and advancing innovations. In addition, the Director Regulatory affairs must understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. This role is expected to be a leader, contributing to cross-functional initiatives and influencing the field, as applicable. You may represent Hemab in industry/regulatory forums to lead regulatory innovation. This role is ideally suited to a candidate who is self-motivated and excited by an opportunity to rise to frequent and diverse challenges.

Job Responsibility

  • Develop and execute innovative global regulatory strategies for global development of candidates for treatment of rare, hematological disorders
  • Define, develop, and lead execution of strategies to maximize global regulatory success and achieve program objectives for complex development projects in the rare disease space
  • Keep abreast of new developments in regulatory science and maintain oversight on evolving regulatory landscape and advancing innovations
  • Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
  • Contribute to cross-functional initiatives and influence the field
  • Represent Hemab in industry/regulatory forums to lead regulatory innovation
  • Responsible for complex and potentially multiple projects within the Rare Disease space
  • Development of regulatory strategies related to development and licensure of biologic development products
  • Represent Regulatory Affairs at project team meetings
  • Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions
  • Effectively communicate through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders
  • Proactively anticipate regulatory risks and develop mitigation strategies
  • Accountable for all Regulatory Agency submissions and approvals of assigned projects, overseeing outsourced vendors and/or Hemab internal team members
  • Direct point of contact with health authorities, leads and manages Regulatory Agency meetings
  • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope
  • Participate in or lead departmental and cross-functional taskforces and initiatives
  • Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies
  • Monitor and anticipate trends that impact both regulatory and access environments

Requirements

  • Bachelor’s degree in a scientific subject area coupled with sufficient industry experience
  • Advanced degrees (e.g. MSc, PhD, PharmD, MD) preferred
  • 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience
  • Experience in rare diseases, especially rare hematological disorders, preferred
  • Understands and works effectively with team members and consultants to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations
  • Ability to advise on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice
  • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
  • Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
  • Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally
  • proactively identifies regulatory issues
  • offers creative solutions and strategies, including risk mitigation strategies
  • Demonstrated ability to work well within global teams and success leading cross-functional regulatory work products

Nice to have

  • Advanced degrees (e.g. MSc, PhD, PharmD, MD)
  • Experience in rare diseases, especially rare hematological disorders
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